HealthyPhase 1NCT02201511
A Healthy Volunteer Trial to Gain Information About the Blood Concentrations of PF-06412562 After Oral Administration of a Modified Release Formulation in Fasted and Fed Conditions
A Phase 1 study testing 3 mg PF-06412562 MR tablets_Fasted, 2 x 15 mg PF-06412562 MR tablets_Fasted and 2 x 15 mg PF-06412562 MR tablets_Fed in people with Healthy, run by Pfizer at 1 site in Belgium.
Trial summary
The study is designed to understand the blood concetration of PF-06412562 and its metabolite, PF-06663872, following a single oral dose of a modified release formulation. The study will include two doses of the PF-06412562 modified release formulation to understand the proportionality. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 3 mg PF-06412562 MR tablets_Fasted, 2 x 15 mg PF-06412562 MR tablets_Fasted and 2 x 15 mg PF-06412562 MR tablets_Fed
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2014to Oct 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs);
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- A positive urine drug screen.
- Subjects who have attempted suicide in the past.
- Subjects who have an unexplained history of sudden death in their family
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label Study In Healthy Subjects To Investigate the Pharmacokinetics Of Pf-06412562 Following Single Oral Administration Of Modified Release Formulation In Fasted And Fed States
The study is designed to understand the blood concetration of PF-06412562 and its metabolite, PF-06663872, following a single oral dose of a modified release formulation. The study will include two doses of the PF-06412562 modified release formulation to understand the proportionality. Effect of food on absorption of PF-06412562 from the modified release formulation will also be investigated in this study.
- Conditions
- Healthy
- Being tested
- 3 mg PF-06412562 MR tablets_Fasted, 2 x 15 mg PF-06412562 MR tablets_Fasted, 2 x 15 mg PF-06412562 MR tablets_Fed, 10 mg PF-06412562 IR tablets
- Keywords
- relative bioavailbility, food effect, pharmacokinetics, ALTERATION OF COGNITIVE FUNCTIONS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 mg PF-06412562 MR tablets_FastedDrug
A single modified release tablet with 3 mg PF-06412562 administered after an overnight fast
2 x 15 mg PF-06412562 MR tablets_FastedDrug
Two 15 mg PF-06412562 modified release tablets administered after an overnight fast
2 x 15 mg PF-06412562 MR tablets_FedDrug
Two 15 mg PF-06412562 modified release tablets administered after a high fat breakfast
10 mg PF-06412562 IR tabletsDrug
a single immediate release tablet of 10 mg PF-06412562 after an overnight fast
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: 3 mg PF-06412562 MR tablets_Fasted |
| 2 | Experimental | Not described Receives: Drug: 2 x 15 mg PF-06412562 MR tablets_Fasted |
| 3 | Experimental | Not described Receives: Drug: 2 x 15 mg PF-06412562 MR tablets_Fed |
| 4 | Experimental | Not described Receives: Drug: 10 mg PF-06412562 IR tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax)
Measured: 0-2 days
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: 0-2 days
Time after dose and before the first plasma concentration (Tlag)
Measured: 0-2
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf]
AUC (0 - inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time. It is obtained from AUC (0 - t) plus AUC (t - inf).
Measured: 0- 2 days
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)
Measured: 0-2 days
Plasma Decay Half-Life (t1/2)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Measured: 0-2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2014 (estimated)
- Study startSep 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02201511
- Sponsor's protocol ID
- B7441006
- Other IDs
- 2014-001214-25, 2014
- Status last verified
- Nov 2015
- First submitted
- 24 Jul 2014
- Last updated
- 10 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label Study In Healthy Subjects To Investigate the Pharmacokinetics Of Pf-06412562 Following Single Oral Administration Of Modified Release Formulation In Fasted And Fed States
- ClinicalTrials.gov ID
- NCT02201511
- Acronym / sponsor ID
- B7441006
- Conditions
- Healthy
- Keywords
- relative bioavailbility, food effect, pharmacokinetics, ALTERATION OF COGNITIVE FUNCTIONS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 28 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is designed to understand the blood concetration of PF-06412562 and its metabolite, PF-06663872, following a single oral dose of a modified release formulation. The study will include two doses of the PF-06412562 modified release formulation to understand the proportionality. Effect of food on absorption of PF-06412562 from the modified release formulation will also be investigated in this study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: 3 mg PF-06412562 MR tablets_Fasted |
| 2 | Experimental | Drug: 2 x 15 mg PF-06412562 MR tablets_Fasted |
| 3 | Experimental | Drug: 2 x 15 mg PF-06412562 MR tablets_Fed |
| 4 | Experimental | Drug: 10 mg PF-06412562 IR tablets |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs);
Key exclusion criteria (4 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- A positive urine drug screen.
- Subjects who have attempted suicide in the past.
- Subjects who have an unexplained history of sudden death in their family
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3 mg PF-06412562 MR tablets_FastedA single modified release tablet with 3 mg PF-06412562 administered after an overnight fast | Drug | Arm 1 |
| 2 x 15 mg PF-06412562 MR tablets_FastedTwo 15 mg PF-06412562 modified release tablets administered after an overnight fast | Drug | 2 |
| 2 x 15 mg PF-06412562 MR tablets_FedTwo 15 mg PF-06412562 modified release tablets administered after a high fat breakfast | Drug | 3 |
| 10 mg PF-06412562 IR tabletsa single immediate release tablet of 10 mg PF-06412562 after an overnight fast | Drug | 4 |
Primary outcome
Maximum Observed Plasma Concentration (Cmax)
Time frame: 0-2 days
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 0-2 days
Time after dose and before the first plasma concentration (Tlag)
Time frame: 0-2
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf]
Time frame: 0- 2 days
AUC (0 - inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time. It is obtained from AUC (0 - t) plus AUC (t - inf).
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
Time frame: 0-2 days
AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)
Plasma Decay Half-Life (t1/2)
Time frame: 0-2 days
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2015.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 3 mg PF-06412562 MR tablets_Fasted, 2 x 15 mg PF-06412562 MR tablets_Fasted and 2 x 15 mg PF-06412562 MR tablets_Fed in people with Healthy, run by Pfizer at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Observed Plasma Concentration (Cmax) (time frame: 0-2 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2015.